Abstract

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials.

• Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries
• Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting
• Case studies outline successes, failures, lessons learned and prospects for future collaboration
• Includes country-specific guidelines for the most utilized countries
• Foreword by David Feigel, former Head of CDRH at FDA

"...can be considered a manual on how an ethical global clinical trial should be conducted....a landmark publication; it likely will stand as a standard reference book for global clinical trials for many years to come." --Journal of the American Medical Association, May 2012

"Global Clinical Trials: Effective Implementation and Management” is probably the most comprehensive book written to date on the topic…The book includes contributions from 59 authors, with coverage of many countries engaged in clinical research." --Journal of Clinical Research Best Practices, May 2012